Delving into the Latest Updates on HS-IT101 with Synapse

Overview

Basic Info

Drug Type

TIL therapy

Synonyms

FAST-TIL, HS IT101, HSIT101

Target-

Action-

Mechanism

Immunologic cytotoxicity, T lymphocyte replacements

Therapeutic Areas

NeoplasmsEye DiseasesRespiratory Diseases+ [3]

Active Indication

Advanced Lung Non-Small Cell CarcinomaMetastatic melanomaUveal Melanoma+ [6]

Inactive Indication-

Originator Organization

Qingdao Sino-cell Biomedicine Co., Ltd.

Active Organization

Qingdao Sino-cell Biomedicine Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced melanoma.

Start Date10 Jul 2025

Sponsor / Collaborator

Qingdao Sino-cell Biomedicine Co., Ltd.

NCT06342336

/ RecruitingPhase 1

Single Arm, Phase I Clinical Study of HS-IT101 Injection in the Treatment of Advanced Solid Tumors

Single-arm, open-label,interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocyte (TIL) infusion (HS-IT101) after lymphodepletion preparative with fludarabine and cyclophosphamide regimen, followed by IL-2, for the treatment of patients with advanced solid tumor.

Start Date18 Jan 2024

Sponsor / Collaborator

Qingdao Sino-cell Biomedicine Co., Ltd.

[+3]

100 Clinical Results associated with HS-IT101

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100 Translational Medicine associated with HS-IT101

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100 Patents (Medical) associated with HS-IT101

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1

Literatures (Medical) associated with HS-IT101

Experimental Hematology & Oncology

Novel tumor-infiltrating lymphocytes therapy in solid tumors: latest updates from 2025 ASCO annual meeting

Letter

Author: Feng, Huijing ; Su, Xuan ; Ma, Yanan

Abstract:

Tumor-infiltrating lymphocyte (TIL) therapy, a highly promising form of adoptive cell therapy (ACT), has demonstrated success in treating advanced melanoma. Notably, innovative TIL-based monotherapies and combination regimens have provided durable clinical responses and survival benefits for patients with various solid tumors. This article summarizes recent advances in TIL therapy for solid tumors presented at the 2025 ASCO Annual Meeting, highlighting monotherapies such as Lifileucel, LM103, OBX-115, GT101, GT300, GT201, and HS-IT101, as well as combination strategies with the oncolytic adenovirus TILT-123 or pembrolizumab.

100 Deals associated with HS-IT101

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Non-Small Cell Carcinoma	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	13 Aug 2025
Metastatic melanoma	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	10 Jul 2025
Uveal Melanoma	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	10 Jul 2025
Advanced Malignant Solid Neoplasm	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	13 Dec 2023
Advanced breast cancer	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	08 Oct 2022
Head and Neck Neoplasms	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	-
Non-Small Cell Lung Cancer	Phase 1	China	Qingdao Sino-cell Biomedicine Co., Ltd.	-
Uterine Cervical Cancer	IND Approval	China	Qingdao Sino-cell Biomedicine Co., Ltd.	30 Nov 2023
Soft Tissue Neoplasms	Preclinical	China	Qingdao Sino-cell Biomedicine Co., Ltd.	01 Dec 2024

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06342336 (HS-IT101ST01-I, ESMO2025) Manual	Phase 1	Melanoma	8	FAST-TIL (HS-IT101) + low-dose IL-2	abjrexjtdm(aschitembm) = ieqrcsrtqe fvffdmqpyg (ydhgeksrbw )	Positive	17 Oct 2025
NCT06342336 (HS-IT101ST01-I, ESMO2025) Manual	Phase 1	Melanoma	8	FAST-TIL (HS-IT101) + low-dose IL-2 (middle-dose non-myeloablative conditioning (MD-NMA))	abjrexjtdm(aschitembm) = ryvplzzpav fvffdmqpyg (ydhgeksrbw ) View more	Positive	17 Oct 2025
NCT06342336 (NEWS) Manual	Phase 1	Metastatic melanoma	1	HS-IT101	wtxfrbwbuv(qgmzfuaqnd) = unqpfzcepo dldqradlum (oqialjzoas )	Positive	26 Nov 2024